QSYMIA Drug Patent Profile

When do Qsymia patents expire, and what generic alternatives are available?

Qsymia is a drug marketed by Vivus Llc and is included in one NDA. There are six patents protecting this drug and one Paragraph IV challenge.

This drug has forty patent family members in seventeen countries.

The generic ingredient in QSYMIA is phentermine hydrochloride; topiramate. There are seventeen drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the phentermine hydrochloride; topiramate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Qsymia

A generic version of QSYMIA was approved as phentermine hydrochloride; topiramate by ACTAVIS LABS FL INC on June 25^th, 2024.

Summary for QSYMIA

International Patents:	40
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	4
Clinical Trials:	20
Drug Prices:	Drug price information for QSYMIA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for QSYMIA
What excipients (inactive ingredients) are in QSYMIA?	QSYMIA excipients list
DailyMed Link:	QSYMIA at DailyMed

See drug prices for QSYMIA

Recent Clinical Trials for QSYMIA

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of Minnesota	PHASE3
Mayo Clinic	PHASE4
University of Toronto	PHASE4

See all QSYMIA clinical trials

Pharmacology for QSYMIA

Drug Class	Sympathomimetic Amine Anorectic
Mechanism of Action	Cytochrome P450 2C19 Inhibitors Cytochrome P450 3A4 Inducers
Physiological Effect	Appetite Suppression Decreased Central Nervous System Disorganized Electrical Activity Increased Sympathetic Activity

Paragraph IV (Patent) Challenges for QSYMIA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
QSYMIA	Extended-release Capsules	phentermine hydrochloride; topiramate	3.75 mg/23 mg 7.5 mg/46 mg 11.25 mg/69 mg 15 mg/92 mg	022580	1	2013-07-18

US Patents and Regulatory Information for QSYMIA

QSYMIA is protected by six US patents and two FDA Regulatory Exclusivities.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Vivus Llc	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-004	Jul 17, 2012	AB	RX	Yes	Yes
Vivus Llc	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-004	Jul 17, 2012	AB	RX	Yes	Yes			Y
Vivus Llc	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-004	Jul 17, 2012	AB	RX	Yes	Yes			Y
Vivus Llc	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-001	Jul 17, 2012	AB	RX	Yes	No

Expired US Patents for QSYMIA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Vivus Llc	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-002	Jul 17, 2012
Vivus Llc	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-004	Jul 17, 2012
Vivus Llc	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-001	Jul 17, 2012
Vivus Llc	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-002	Jul 17, 2012

International Patents for QSYMIA

When does loss-of-exclusivity occur for QSYMIA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

Chile

China

Cyprus

Denmark

European Patent Office

Hong Kong

Israel

Japan

Mexico

Portugal

South Africa

South Korea

Spain

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering QSYMIA around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1187603	THERAPIE COMBINEE PERMETTANT DE PERDRE DU POIDS ET DE TRAITER L'OBESITE (COMBINATION THERAPY FOR EFFECTING WEIGHT LOSS AND TREATING OBESITY)
Japan	6077053
Brazil	9710994
World Intellectual Property Organization (WIPO)	2009152189

Supplementary Protection Certificates for QSYMIA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2317997	CR 2021 00049	Denmark		PRODUCT NAME: PHENTERMIN OG TOPIRAMAT; NAT. REG. NO/DATE: 63166, 63167, 63168, 63169 20210705; FIRST REG. NO/DATE: IS IS/1/21/018/01-04 20210212
2317997	2190050-1	Sweden		PRODUCT NAME: PHENTERMINE AND TOPIRAMATE; NAT. REG. NO/DATE: 59574-59577 20210617; FIRST REG.: IS IS/1/21/018/01-04 20210212
2317997	CA 2021 00049	Denmark		PRODUCT NAME: PHENTERMIN OG TOPIRAMAT; NAT. REG. NO/DATE: 63166, 63167, 63168, 63169 20210705; FIRST REG. NO/DATE: IS IS/1/21/018/01-04 20210212
2317997	833	Finland

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: QSYMIA

Last updated: July 27, 2025

Introduction

QSYMIA, a prescription medication for weight management, has carved a niche within the obesity treatment segment since its approval by the U.S. Food and Drug Administration (FDA) in 2012. Combining phentermine and topiramate extended-release, it offers an innovative pharmacological approach to combat obesity—an escalating global health challenge. This article analyzes the market dynamics influencing QSYMIA’s commercial environment and forecasts its financial trajectory by examining regulatory factors, competitive landscape, patient adoption trends, and broader healthcare industry shifts.

Regulatory Environment and Market Entry

The path to commercial viability for QSYMIA has been significantly shaped by regulatory policies. FDA approval in 2012 marked a pivotal moment, validating the drug’s efficacy and safety profile, despite warnings related to potential teratogenicity and cardiovascular risks (see [1]). Strict labeling and Risk Evaluation and Mitigation Strategy (REMS) requirements have mandated healthcare provider education and patient monitoring, influencing market penetration strategies.

Regulatory hurdles delay competitor entry and influence pricing dynamics. The FDA’s post-marketing surveillance continues to influence the drug’s market standing, as safety signals or new evidence could necessitate label updates or restrictions. Additionally, international regulatory approvals — such as the European Medicines Agency (EMA) decisions — remain pivotal for global expansion but have yet to favor QSYMIA’s widespread inroads beyond the U.S.

Market Demand Drivers

Obesity’s rising prevalence—affecting over 700 million adults globally according to WHO—serves as the primary demand driver ([2]). The increasing burden on healthcare systems and the push toward modular, algorithmic approaches to weight management boost demand for pharmacotherapies like QSYMIA. Furthermore, the FDA’s recognition of pharmacological options as essential adjuncts to lifestyle modifications enhances clinician willingness to prescribe QSYMIA.

However, medical practitioners exercise caution owing to safety concerns, leading to conservative prescribing practices. Insurance coverage remains inconsistent; high out-of-pocket costs inhibit patient access, impacting overall market uptake. An increase in awareness about weight-related comorbidities, including diabetes and cardiovascular disease, augments the drug’s perceived value.

Competitive Landscape

QSYMIA operates within a competitive marketplace featuring several pharmacological agents:

• Orlistat (Xenical, Alli): A lipase inhibitor with a longer market presence but with less efficacy in weight loss.
• Liraglutide (Saxenda): An injectable GLP-1 receptor agonist, gaining favor due to dual metabolic and appetite regulation.
• Contrave (naltrexone/bupropion): An oral dopaminergic and opioid antagonist.
• Semaglutide (Wegovy): Recent FDA approval for weight management demonstrates a shifting landscape favoring GLP-1 based therapies.

QSYMIA’s differentiated mechanism through combination pharmacotherapy initially provided a competitive edge but faces challenges from newer agents with improved safety profiles. The efficacy-to-safety balance remains central, with cardio-metabolic benefits increasingly prioritized. The ongoing pipeline developments, including novel dual-action agents, threaten to erode QSYMIA’s market share.

Patient Population and Prescribing Trends

The segment of patients eligible for QSYMIA is primarily characterized by moderate to severe obesity (BMI ≥30 kg/m^2) or BMI ≥27 kg/m^2 with comorbidities. Historically, prescriber hesitance, driven by adverse effect concerns such as teratogenicity, led to modest market penetration. Advancements in screening, lab diagnostics, and clinical guidelines now support broader prescribing.

Recent data indicate a gradual uptick in prescriptions, propelled by increased awareness and supportive guidelines. Nonetheless, adherence remains an issue—side effects like dry mouth, paresthesias, and cognitive effects contribute to discontinuation, impacting long-term sales.

Pricing, Reimbursement Landscape, and Revenue Potential

Pricing strategies for QSYMIA are competitive but constrained by healthcare payers’ cost containment policies. With a retail price averaging approximately $200-$250 per unit (per monthly pack), access is limited by insurance coverage gaps. Reimbursement complexities, coupled with safety warnings, have led to cautious formulary placements.

The revenue trajectory hinges upon improved payer acceptance, expanded indications, and increased prescriber comfort. Analysts project modest growth over the next five years, contingent on successful safety management and the emergence of complementary or replacement therapies.

Emerging Trends Influencing Future Market Trajectory

• Biologics and Gene Therapy: Advances in biologics targeting metabolic regulators threaten to redefine obesity pharmacotherapy, possibly displacing small molecules like QSYMIA.
• Personalized Medicine: Genetic profiling informs tailored weight management plans, potentially reducing pharmaceutical reliance.
• Digital Health Integration: Mobile health apps and remote monitoring foster better adherence, possibly mitigating some safety concerns and leading to higher prescription rates.
• Regulatory Shift Toward Holistic Approaches: Increasing emphasis on comprehensive lifestyle intervention models may diminish reliance on pharmacotherapy, impacting overall drug sales.

Financial Outlook

Projecting QSYMIA’s financial performance involves multi-factorial analysis:

• Revenue Growth: Anticipated to remain modest due to cautious prescribing patterns, safety concerns, and competition. An average annual growth rate of 3-5% is expected, assuming ongoing marketing efforts and payer negotiations.
• Profit Margins: Stable with cost containment and pricing strategies; however, competition and regulatory pressures could compress margins.
• Market Penetration: Limited expansion outside the U.S.—particularly in Europe—is likely until regulatory hurdles are surmounted.

In conclusion, while QSYMIA retains a niche role in obesity pharmacotherapy, its long-term financial trajectory faces headwinds from safety concerns, intense competition, and industry shifts favoring biologic therapies.

Key Takeaways

• Regulatory and safety considerations critically influence QSYMIA’s market acceptance and expansion.
• The growing obesity epidemic sustains demand but is counterbalanced by clinician caution and payer restrictions.
• Competitive innovation, especially within GLP-1 receptor agonists like semaglutide, challenges QSYMIA’s market share.
• Market growth is subdued, with moderate long-term revenue potential contingent on safety, cost-effectiveness, and evolving treatment paradigms.
• Integration with digital health platforms and personalized medicine strategies offers opportunities to enhance market presence.

FAQs

1. What are the primary safety concerns associated with QSYMIA?

QSYMIA carries warnings for teratogenicity, cardiovascular risks, and cognitive side effects. Its use requires careful patient screening and adherence to REMS protocols to mitigate adverse events.

2. How does QSYMIA compare to newer weight management therapies?

While QSYMIA offers effective weight loss, newer agents like semaglutide provide greater efficacy and potentially better safety profiles, leading to increased prescriber preference in some markets.

3. What is the outlook for QSYMIA’s global market expansion?

Regulatory barriers and safety concerns have limited international adoption. Success in global markets depends on demonstrating an improved safety profile and strategic approval processes.

4. How does insurance coverage impact QSYMIA's sales?

Limited insurance reimbursement constrains patient access, leading to higher out-of-pocket costs and dampening overall sales potential, especially among cost-sensitive populations.

5. What strategic moves could enhance QSYMIA’s market position?

Innovations in formulation to reduce side effects, expanded indications, improved payer negotiations, and integration with digital health tools may bolster its market share and financial performance.

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References

[1] U.S. Food and Drug Administration. (2012). FDA approves Qsymia for chronic weight management.
[2] World Health Organization. (2021). Obesity and overweight.